Ewan also advises on the regulatory issues that frequently arise in the context of those transactions and throughout the medicinal product life cycle, particularly in relation to marketing authorisations, manufacturing, distribution, advertising, pricing and reimbursement. He is also a member of the firm's cannabis team and advises companies on the licensing regime, import, manufacture, distribution and promotion of cannabis-based medicinal products.

In addition to his work in private practice, Ewan has spent time in-house with GlaxoSmithKline and Gilead in London, and Novartis in Sydney.

Ewan has a degree in natural sciences from Cambridge University, and studied law at a post-graduate level.

Focus Areas

Experience

Commercial

Regulatory

AstraZeneca in the negotiation of an exclusive research collaboration and licensing agreement to co-develop five engineered oncolytic vaccinia virus candidates with Transgene, a French biotech company.

Santen Pharmaceutical Co. in the negotiation of a collaboration agreement to research and develop gene therapy products for the treatment of an inherited retinal disease.

Novartis on its licensing and supply agreement with Spark Therapeutics for development, registration and commercialization rights outside the US, for one-time gene therapy known as Luxturna.

Global pharmaceutical company in negotiating a variety of inter-related agreements with its suppliers and contract manufacturers relating to the development, contract manufacture and supply of an injectable diabetes product.

Global pharmaceutical company in negotiating a product transfer and subsequent supply agreements relating to a range of medicated pastilles and nutritional products.

Global pharmaceutical company on rebate agreements relating to the supply of its product to health bodies across the UK.

Global pharmaceutical company in drafting and implementing a suite of clinical trial agreements for use in its worldwide clinical trials programme.

Various pharmaceutical companies on the regulatory aspects of supply chain structuring, including the requirement to hold manufacturing, import and wholesale distribution authorisations and cross border issues.

Various pharmaceutical companies on the impact of EU legislation relating to falsified medicines on their supply chains, including restrictions on the importation of active pharmaceutical substances and related licensing requirements.

Global pharmaceutical company in its challenge in the UK Court of a decision of the Medicines and Healthcare products Regulatory Agency (MHRA) to award a parallel import licence to a competing generic manufacturer.

Global pharmaceutical company on the risks of off-label promotion of medicinal products in Europe.

Multinational company on data protection issues arising from the transfer of personal data between the US and the EU.

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